Mindfulness-based Neurofeedback to Augment Psychotherapy for Adults With Borderline Personality Disorder
MIND-BPD
2 other identifiers
interventional
150
1 country
1
Brief Summary
The purpose of this study is to test the ability of mindfulness-based real time functional magnetic resonance imaging (fMRI) neurofeedback (mbNF) to increase the benefits of evidence-based psychotherapy for adults with Borderline Personality Disorder (BPD).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2025
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 30, 2024
CompletedFirst Posted
Study publicly available on registry
June 6, 2024
CompletedStudy Start
First participant enrolled
March 13, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 30, 2026
June 5, 2025
June 1, 2025
1.2 years
May 30, 2024
June 4, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in within-Default Mode Network (DMN) resting state functional connectivity after one session of neurofeedback (NF)
Defined as within-DMN connectivity as the resting state seed-based connectivity between core nodes of medial prefrontal cortex (mPFC) and posterior cingulate cortex (PCC). Change = post-NF within-DMN connectivity - pre-NF within-DMN connectivity.
From baseline (immediately before neurofeedback) to immediately after neurofeedback on the same day
Change in DMN-Frontoparietal Control Network (FPCN) anticorrelation in resting state functional connectivity data after one session of neurofeedback
Defined as DMN-FPCN anticorrelation as the fMRI seed-based connectivity from mPFC to dorsolateral prefrontal cortex (dlPFC)). Change = post-NF mPFC-dlPFC anticorrelation - pre-NF mPFC-dlPFC anticorrelation
From baseline (immediately before neurofeedback) to immediately after neurofeedback on the same day
Secondary Outcomes (1)
Change from baseline in state mindfulness on State Mindfulness Scale (SMS) score on same day after neurofeedback.
From baseline (immediately before neurofeedback) to immediately after neurofeedback on the same day
Study Arms (2)
mindfulness-based Neurofeedback
EXPERIMENTALParticipants will participate in one session of mindfulness-based fMRI neurofeedback followed by 20 weeks of remote online weekly Dialectical Behavior Therapy skills group.
control Neurofeedback
OTHERParticipants will participate in one session of control fMRI neurofeedback followed by 20 weeks of remote online weekly Dialectical Behavior Therapy skills group.
Interventions
Participants will complete one session of mindfulness-based fMRI neurofeedback prior to 20 weeks of remote online weekly DBT skills group.
Participants will complete one session of control fMRI neurofeedback prior to 20 weeks of remote online weekly DBT skills group.
Eligibility Criteria
You may qualify if:
- age 18-60,
- be able to provide written informed consent,
- meet criteria for BPD on semi-structured clinical interview,
- able to plan to keep any prescribed medications and psychotherapy constant during the study
- fluent in English.
You may not qualify if:
- current DBT psychotherapy outside the study
- lifetime primary psychotic disorder or Bipolar I disorder
- developmental disorder (e.g. autism)
- history of learning disorder
- moderate or severe substance use disorder in the last 6 months
- active suicidal ideation with intent or plan in the past 3 months
- history of major medical or neurologic disorder
- MRI contraindications, including pregnancy
- poor performance on reading task (WRAT \> 11 errors)
- newly prescribed medications in the past 8 weeks
- daytime sedating medications (e.g. benzodiazepines, opiates, sedating neuroleptics)
- any scheduled daily benzodiazepines
- change in psychotherapy type or frequency in the past 12 weeks.
- At the discretion of the study PI
- Eligibility will be determined by study personnel.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yale Universitylead
- Connecticut Mental Health Centercollaborator
- National Institute of Mental Health (NIMH)collaborator
Study Sites (1)
Connecticut Mental Health Center
New Haven, Connecticut, 06519, United States
Related Publications (1)
Jones KG, Vandewouw MM, Awasthi J, Alario AA, Bauer C, Brewer B, Campbell N, Denning D, Greene KD, Hammoud J, Hinds O, Huffman S, Maerker C, Paprotna S, Qiu M, Swinchoski B, Taylor A, Waite E, Wighton P, Whaley M, Papa J, Gordon KD, Hampson M, Whitfield-Gabrieli S, Fineberg SK. A protocol for MIndfulness-based Neurofeedback to augment DBT psychotherapy for adults with Borderline Personality Disorder (MIND-BPD). medRxiv [Preprint]. 2025 Nov 19:2025.11.18.25340531. doi: 10.1101/2025.11.18.25340531.
PMID: 41332880DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sarah K Fineberg, MD PhD
Yale University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 30, 2024
First Posted
June 6, 2024
Study Start
March 13, 2025
Primary Completion (Estimated)
May 30, 2026
Study Completion (Estimated)
May 30, 2026
Last Updated
June 5, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will share
Sharing will occur as required by NIMH through the National Data Archive.